Senior CRA

ClinicalPro is seeking a Senior CRA for a leading CRO located in the USA.

This individual will be responsible for supervising the trial’s execution. The individual will make sure that the trial complies with the authorised protocol (and/or revisions).

with Good Clinical Practices, and with the standards established by the relevant regulatory bodies. 

Must be eligible to work in the USA.

Responsibilities

• Assessment of monitoring schedules, KPIs, and visit reports to broaden the scope of site management.
• Take part in monitoring and initiation visits to research sites.
• Control the way that the clinical sites execute their daily operations.
• Engage and instruct the employees at the clinical location.
• Participate in the project scope, vendor requirements preparation, and research vendor selection.
• Controlling suppliers will ensure prompt and high-quality outputs. Create trackers for managing samples.
• Maintain enrollment and recruiting data, give Clinical Development weekly study updates, and present slides.
• Maintain clinical trial files in accordance with ICH guidelines; implement suitable systems, standards, and processes to assure quality at the level of investigational sites, vendors, and data.
• Make sure the Clinical Monitoring Plan is followed.
• Lead and participate in weekly CRA meetings.
• Update CTL and other stakeholders on study progress.
• Proactively identify and address problems.
• Control the escalation of study-related problems.
• Participate in cross-functional study execution team meetings and, if necessary, assist them. Work with other functional areas to plan clinical trial activities.
• Participate in the protocol, CRF, CSR, and other important research team deliverables preparation and assure operational quality.
• Review and/or write study metrics, reports, and clinical trial designs.
• Participate in the evaluation of the research’s viability and the choice of the nation and location for the study.
• Attend investigator meetings and take part in the development and delivery of study-specific training.
• All work must follow SOPs and ICH Good Clinical Practice (GCP) criteria.

Skills and Requirements

• Bachelor’s degree is necessary.
• 5 or more years of CRA experience in a CRO or pharmaceutical environment is necessary.
• A working knowledge of ICH/GCP guidelines and the clinical research procedure.
• Microsoft Word, Excel, PowerPoint, and Outlook proficiency is necessary.
• Have knowledge about and the capacity to master new clinical systems
• Expertise in EDC, IVRS, CTMS, eTMF, and other clinical project management tools.
• Excellent oral and written communication skills.
• Requires outstanding analytical and problem-solving abilities.
• Requires the capacity for self-motivation, teamwork, proactive task management, and the ability to balance conflicting demands in a quick-paced setting.

Apply

If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.

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